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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Specialty Task Group Area: Software/Informatics
 
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07/09/2014 Software/
Informatics		 13-69 Complete ISO IEEE 11073-10472 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor
06/27/2016 Software/
Informatics		 13-83 Complete AAMI TIR57:2016 Principles for medical device security - Risk management.
12/23/2024 Software/
Informatics		 13-141 Complete ISO IEEE 11073-10701 First Edition, 2024-09 Health Informatics - Device Interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System
IEEE Std 11073-10701-2022 Health informatics - Device interoperability Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system
05/26/2025 InVitro Diagnostics 7-344 Complete CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
12/04/2017 Software/
Informatics		 13-103 Complete IEC TR 80001-2-9 Edition 1.0 2017-01 Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
01/15/2013 Software/
Informatics		 13-34 Complete ANSI AAMI IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1 Edition 1.0 2009-09 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
12/23/2016 Software/
Informatics		 13-87 Complete ISO IEC 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
07/09/2014 Software/
Informatics		 13-65 Complete UL ANSI 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
01/30/2014 Software/
Informatics		 13-63 Complete ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
08/21/2017 Software/
Informatics		 13-97 Complete IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
12/22/2025 Software/
Informatics		 13-150 Complete ISO IEEE 11073-10472 Second edition 2024-09 Health informatics - Device Interoperability - Part 10472: Personal health device communication - Device specialization - Medication monitor
IEEE Std 11073-10472-2023 Health informatics - Device Interoperability - Part 10472: Personal Health Device Communication - Device Specialization - Medication Monitor
01/27/2015 Software/
Informatics		 13-72 Complete ISO IEEE 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
05/29/2024 Software/
Informatics		 13-133 Complete ISO IEEE 11073-10415 Second edition 2022-12 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
IEEE Std 11073-10415-2019 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
05/26/2025 InVitro Diagnostics 7-334 Complete CLSI AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
05/26/2025 InVitro Diagnostics 7-335 Complete CLSI POCT01-A2 Point-of-Care Connectivity - Second Edition
05/26/2025 InVitro Diagnostics 7-336 Complete CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition.
05/26/2025 InVitro Diagnostics 7-340 Complete CLSI LIS01-A2 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems - Second Edition.
05/26/2025 InVitro Diagnostics 7-338 Complete CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
05/26/2025 InVitro Diagnostics 7-339 Complete CLSI AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
06/27/2016 Software/
Informatics		 13-84 Complete ISO IEEE 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
10/19/2020 Software/
Informatics		 13-116 Complete FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
05/26/2025 Software/
Informatics		 13-145 Complete IEEE Std 11073-10419:2023 Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump
08/06/2013 Software/
Informatics		 13-56 Complete ISO IEEE 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
01/27/2015 Software/
Informatics		 13-70 Complete ANSI AAMI IEC TIR80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
IEC TR 80001-2-5 Edition 1.0 2014-12 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
08/06/2013 Software/
Informatics		 13-60 Complete IEC TS 62443-1-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
05/26/2025 Software/
Informatics		 13-144 Complete ISO IEEE 11073-10425 Edition 3, 2024-09 Health informatics - Device interoperability Part 10425: Personal health device communication - Device specialization - Continuous Glucose Monitor (CGM)
IEEE Std 11073-10425-2023 Health informatics - Device Interoperability Part 10425: Personal Health Device Communication - Device Specialization - Continuous Glucose Monitor (CGM)
05/26/2025 Software/
Informatics		 13-147 Complete IEEE Std 11073-10406-2023 Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
05/29/2024 Software/
Informatics		 13-132 Complete ISO IEEE 11073-10408 Second edition 2022-12 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
IEEE Std 11073-10408-2019 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
10/09/2023 Software/
Informatics		 13-130 Complete ANSI AAMI 2700-2-1:2022 Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
07/06/2020 Software/
Informatics		 13-113 Complete IEEE Std 11073-20601-2019 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
07/06/2020 Software/
Informatics		 13-114 Complete IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
05/29/2024 Software/
Informatics		 13-134 Complete ISO IEEE 11073-10404 Second edition 2022-12 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
IEEE Std 11073-10404-2020 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
10/09/2023 Software/
Informatics		 13-131 Complete ANSI AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers
05/26/2025 InVitro Diagnostics 7-337 Complete CLSI AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline
05/25/2026 Software/
Informatics		 13-140 Complete FIRST CVSS v4.0 Common Vulnerability Scoring System version 4.0
05/26/2025 Software/
Informatics		 13-142 Complete FIRST CVSS v3.1 Common Vulnerability Scoring System version 3.1
12/19/2022 Software/
Informatics		 13-121 Complete ANSI AAMI UL 2800-1:2022 Standard for Medical Device Interoperability
05/26/2025 InVitro Diagnostics 7-342 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
05/26/2025 InVitro Diagnostics 7-332 Complete CLSI AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
05/26/2025 InVitro Diagnostics 7-341 Complete CLSI AUTO03-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition
05/26/2025 InVitro Diagnostics 7-343 Complete CLSI AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
05/26/2025 InVitro Diagnostics 7-345 Complete CLSI AUTO13-A2 (Formerly GP19-A2) Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
08/14/2015 Software/
Informatics		 13-78 Complete INCITS ISO IEC 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
05/26/2025 Software/
Informatics		 13-143 Complete AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software
01/15/2013 Software/
Informatics		 13-36 Complete AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
04/04/2016 Software/
Informatics		 13-81 Complete ISO IEEE 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
05/26/2025 Software/
Informatics		 13-148 Complete IEEE Std 11073-10417-2023 Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter
05/26/2025 Software/
Informatics		 13-146 Complete IEEE Std 11073-10103 Second edition 2023 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
05/25/2026 Software/
Informatics		 13-158 Complete IEEE Std 1752.1-2021 Open Mobile Health Data: Representation of Metadata, Sleep, and Physical Activity Measures
08/06/2013 Software/
Informatics		 13-44 Complete ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
05/29/2024 Software/
Informatics		 13-136 Complete ISO IEEE 11073-20601 Third Edition 2022-12 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol
ISO IEEE 11073-20601-2019 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol
05/26/2025 InVitro Diagnostics 7-331 Complete CLSI AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition
05/29/2024 Software/
Informatics		 13-138 Complete ISO IEEE 11073-10700 First Edition 2024-09 Health informatics - Device interoperability Part 10700: Point-of-care medical device communication - Standard for base requirements for participants in a Service-oriented Device Connectivity (SDC) system
IEEE Std 11073-10700-2022 Health Informatics - Device Interoperability Part 10700: Point-of-Care Medical Device Communication - Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System
05/29/2024 Software/
Informatics		 13-135 Complete ISO IEEE 11073-10407 Second edition 2022-12 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
IEEE Std 11073-10407-2020 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
05/29/2024 Software/
Informatics		 13-139 Complete ISO IEEE 11073-10206:2024 Health informatics - Device interoperability Part 10206: Personal health device communication - Abstract content information model
IEEE Std 11073-10206-2022 Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model
05/25/2026 Software/
Informatics		 13-157 Complete IEEE Std 11073-10207-2017 [Including Cor 1-2025] Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication [Including Corrigendum 1 (2025)]
08/06/2013 Software/
Informatics		 13-42 Complete ANSI AAMI IEC TIR 80001-2-2:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TR 80001-2-2 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
12/04/2017 Software/
Informatics		 13-99 Complete ISO IEC 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
08/14/2015 Software/
Informatics		 13-74 Complete IEEE Std 11073-10424-2014 Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
12/19/2022 Software/
Informatics		 13-123 Complete ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
12/04/2017 Software/
Informatics		 13-102 Complete IEC TR 80001-2-8 Edition 1.0 2016-05 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
06/27/2016 Software/
Informatics		 13-82 Complete ANSI AAMI ISO TIR 80001-2-6:2014 Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
12/04/2017 Software/
Informatics		 13-98 Complete ISO IEC 646 Third edition 1991-12-15 (R2018) Information technology - ISO 7-bit coded character set for information interchange
INCITS ISO IEC 646:1991 (R2018) Information technology - ISO 7-bit coded character set for information interchange
08/21/2017 Software/
Informatics		 13-90 Complete ISO IEEE 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
IEEE Std 11073-10417-2015 Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
01/15/2013 Software/
Informatics		 13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
12/19/2022 Software/
Informatics		 13-122 Complete IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022 Software/
Informatics		 13-124 Complete AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
12/19/2022 Software/
Informatics		 13-125 Complete ANSI AAMI UL 2800-1-1:2022 Standard for Risk Concerns for Interoperable Medical Products
12/04/2017 Software/
Informatics		 13-101 Complete ISO IEC 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
06/07/2021 Software/
Informatics		 13-118 Complete IEEE Std 11073-40102:2020 Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation.
06/07/2021 Software/
Informatics		 13-119 Complete ANSI ISA 62443-4-1-2018 Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements.
08/06/2013 Software/
Informatics		 13-55 Complete IEEE Std 11073-10421-2010 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
12/04/2017 Software/
Informatics		 13-100 Complete ISO IEC 15459-4 Third edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
07/06/2020 Software/
Informatics		 13-115 Complete ISO IEC IEEE 29119-1 First edition 2013-09-01 Software and systems engineering - Software testing - Part 1: Concepts and definitions
08/21/2017 Software/
Informatics		 13-67 Complete ISO IEEE 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
IEEE Std 11073-10418-2011 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor
01/14/2019 Software/
Informatics		 13-105 Complete ANSI AAMI SW91:2018 Classification of defects in health software
01/14/2019 Software/
Informatics		 13-106 Complete ISO IEEE 11073-10207-2019 Health informatics - Point-of-care medical device communication Part 10207: Domain information and service model for service-oriented point-of-care medical device communication
IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
07/15/2019 Software/
Informatics		 13-108 Complete IEEE Std 11073-20701-2018 Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding
12/19/2022 Software/
Informatics		 13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
01/14/2019 Software/
Informatics		 13-107 Complete ISO IEEE 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services
12/23/2016 Software/
Informatics		 13-86 Complete ISO IEC 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
08/06/2013 Software/
Informatics		 13-59 Complete ISO IEC IEEE 15026-4 First edition 2021-10-01 Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
08/06/2013 Software/
Informatics		 13-61 Complete IEC 62443-2-1 Edition 1.0 2010-11 Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
01/14/2019 Software/
Informatics		 13-79 Complete IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
12/19/2022 Software/
Informatics		 13-127 Complete ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
01/15/2013 Software/
Informatics		 13-35 Complete ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
08/14/2015 Software/
Informatics		 13-77 Complete ISO IEC 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
08/14/2015 Software/
Informatics		 13-75 Complete ISO IEEE 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/06/2013 Software/
Informatics		 13-62 Complete IEC TR 62443-3-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
08/14/2015 Software/
Informatics		 13-76 Complete ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
05/26/2025 InVitro Diagnostics 7-333 Complete CLSI AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
12/22/2025 Software/
Informatics		 13-152 Complete ISO TS 5615:2025 Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics
08/21/2017 Software/
Informatics		 13-94 Complete ISO IEEE 11073-10424 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
08/06/2013 Software/
Informatics		 13-49 Complete ISO IEEE 11073-20101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
08/21/2017 Software/
Informatics		 13-93 Complete ISO IEEE 11073-10422:2017 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
12/23/2019 Software/
Informatics		 13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
12/22/2025 Software/
Informatics		 13-153 Complete AAMI CR515:2025 Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices
12/22/2025 Software/
Informatics		 13-154 Complete IEEE Std 11073-10429-2022 Health informatics - Device Interoperability - Part 10429: Personal Health Device Communication - Device Specialization - Spirometry
12/22/2025 Software/
Informatics		 13-155 Complete IEEE Std 11073-10442-2023 Health informatics - Device Interoperability Part 10442: Personal health device communication - Device specialization - Strength fitness equipment
 
 
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